The device is part of the therapy, not the packaging around it.
In drug delivery the device determines whether the dose arrives as intended. Accuracy, containment, material compatibility, sterility and human factors all directly affect therapeutic outcome.
The regulatory pathway reflects that by evaluating the device and the drug together.
What we build here
Six areas of delivery engineering.
01
Dose accuracy and delivery mechanism design
Mechanisms designed and characterised for accuracy across the full delivery range, not just at the nominal dose.
02
Fluid path and material compatibility
Materials selected and tested against the formulation, over shelf life and under real storage conditions.
03
Containment and sterility considerations
Containment integrity, sterile barrier design and the validation strategy that supports both.
04
Human factors for self-administration
Devices designed for untrained users under stress, and use-related risk analysis that takes that seriously.
05
Connected adherence and monitoring
Dose logging, adherence data and connectivity, built as regulated software with a clear clinical purpose.
06
Combination product regulatory strategy
A pathway that accounts for the device and the drug together, across the markets you are targeting.
Under scrutiny
What gets scrutinised.
01
Dose accuracy across the full delivery range.
02
Use-related risk in the hands of untrained users.
03
Material and fluid path compatibility over shelf life.
In practice
Evidence that covers device and dose.
A combination product is assessed as a whole. The device evidence and the formulation evidence have to agree with each other.
Dose accuracy characterised across the delivery range.
Material compatibility and shelf-life data.
Use-related risk analysis and validation with real users.
A combination product strategy agreed per market.
Next step
Developing a delivery device?
Tell us the formulation, the dose and who will be administering it.